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FDA Recalls and Warnings: Cancer-Linked Impurities in Diuretics, Kidney Drugs; More Eye Drops Recalled
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Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions.
May 5, 2026
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Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Albuterol, Buspirone, Cinacalcet, Claravis, Furosemide, Omega-3-Acid Ethyl Esters, and Pantoprazole. Also, these over-the-counter eye drops are under recall: GenTeal Tears Lubricant Eye Gel Drops, Systane Lubricant Eye Gel, iVIZIA Sterile Lubricant Eye Drops, and Optase Dry Eye Intense Drops.
All of the recalls in this installment have been assigned a “Class II” level by the FDA, except for Buspirone, which was assigned “Class III.” The recall for Claravis has not yet been classified. All are nationwide supplier-level recalls and not directed at consumers. However, consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates.
How to Read This Report
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
Drug Recalls
Albuterol Sulfate Inhalation Solution
Company: Nephron SC, LLC
Manufacturing Location: West Columbia, South Carolina by Nephron 503B Outsourcing Facility Scope: 146,280 vials of 0.5% strength
Drug Purpose: Treats bronchospasm — a narrowing of the airways that makes breathing difficult — in asthma and other lung diseases. This formulation is administered using a nebulizer, which turns the medication into an inhalable mist.
Recall Reason: Problem with labeling; the drug label was illegible.
Recall Initiation Date: March 17, 2026
Essential Extras: Nephron 503B Outsourcing Facility is a division of Nephron Pharmaceuticals Corporation, primarily selling products to hospitals and medical facilities. It is registered at the FDA as Nephron Sterile Compounding Center LLC.
Link: FDA Enforcement Report
BusPIRone Hydrochloride Tablets (generic for Buspar)
Company: Unichem Pharmaceuticals USA Inc.
Manufacturing Location: Ghaziabad, India, by Unichem Laboratories LTD.
Scope: 10,875 (500-count) bottles of 5 mg strength tablets
Drug Purpose: Treats generalized anxiety disorder and/or provides short-term relief of anxiety symptoms
Recall Reason: Subpotent drug; the amount of active ingredient was less than the allowable range.
Recall Initiation Date: April 13, 2026
Link: FDA Enforcement Report
Cinacalcet Hydrochloride Tablets (generic for Sensipar)
Company: Cipla USA, Inc.
Manufacturing Location: Cipla Ltd., MIDC, Patalganga, India
Scope: 113,336 30-count bottles of 30 mg strength; 96,096 30-count bottles of 60 mg strength; 63,192 30-count bottles of 90 mg strength tablets
Drug Purpose: Treats secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: March 16, 2026
Link: FDA Enforcement Report
Claravis Capsules
Drug Name: Claravis (isotretinoin) capsules
Company: Teva Pharmaceuticals USA, Inc.
Manufacturing Location: North Wales, Pennsylvania by Teva
Scope: 5,101 cartons of 10 mg capsules (includes 100-count cartons of 10X10 blister packs and 30-count cartons of 3X10 blister packs)
Drug Purpose: Treats severe cystic acne that has not responded to other treatments
Recall Reason: Impurity levels in tretinoin exceeded acceptable limits, which may affect stability and effectiveness.
Recall Initiation Date: April 6, 2026; this recall is not yet classified; this is a nationwide and Virgin Islands recall.
Link: FDA Enforcement Report
Furosemide Tablets (generic for Lasix)
Company: Leading Pharma, LLC
Manufacturing Location: Fairfield, New Jersey
Scope: 9,384 bottles (100-count) of 80 mg strength tablets
Drug Purpose: Diuretic that treats high blood pressure, heart failure, and edema.
Recall Reason: Presence of nitrosamine impurities above the FDA-recommended limit. Nitrosamine impurities may increase the risk of cancer.
Recall Initiation Date: March 20, 2026
Link: FDA Enforcement Report
Omega-3-Acid Ethyl Esters Capsules (generic for Lovaza)
Company: Harvard Drug Group / Major Pharmaceuticals
Manufacturing Location: Packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana
Scope: 2,238 cartons of 1 g strength, 10-unit dose blister packs of capsules
Drug Purpose: A prescription fish oil–derived treatment used to lower very high triglyceride levels.
Recall Reason: Failed stability testing.
Recall Initiation Date: April 9, 2026
Link: FDA Enforcement Report
Pantoprazole Tablets (generic for Protonix)
Company: Hetero Labs Limited
Manufacturing Location: Mahabubnagar, India; manufactured by Hetero Labs Ltd. for Camber Pharmaceuticals
Scope: 4,740 bottles (1,000-count) of 40 mg strength tablets
Drug Purpose: Proton pump inhibitor used to treat erosive esophagitis, often caused by acid reflux.
Recall Reason: Complaints were received about tablet discoloration.
Recall Initiation Date: March 26, 2026
Link: FDA Enforcement Report
Eye Drop Recalls
GenTeal Tears Lubricant Eye Gel Drops and Systane Lubricant Night Gel
Company: Alcon Research LLC
Manufacturing Location: GenTeal manufacturing location not specified, distributed by Alcon Laboratories; Systane product processed in France for Alcon Laboratories
Scope: Unspecified number of bottles of GenTeal Tears 10 g (0.34 fl oz) and Systane Night Gel 10 g (0.35 oz)
Drug Purpose: Lubricant eye gels that are used to relieve dry eye symptoms
Recall Reason: Lack of assurance of sterility.
Recall Initiation Date: April 21, 2026
Link: FDA Enforcement Report
iVIZIA Sterile Lubricant Eye Drops and Similasan iVIZIA Sterile Lubricant Eye Drops
Company: Thea Pharma
Manufacturing Location: France; distributed by Thea Pharma
Scope: Five lots of 0.33 fl oz (10 mL) bottles (Povidone 0.5%)
Drug Purpose: Lubricant eye drops used to relieve dry eye symptoms
Recall Reason: Lack of assurance of sterility identified during an FDA facility inspection.
Recall Initiation Date: April 23, 2026
Link: FDA Enforcement Report
Essential Extras: iVIZIA posted a detailed recall announcement on its website with lot numbers, product photo, expiration dates, and instructions to consumers: Ivizia Recall Announcement
Optase Dry Eye Intense Drops
Drug Name: Optase Dry Eye Intense Drops
Company: Scope Health
Manufacturing Location: Not specified
Scope: 0.33 fl oz bottles (Glycerin 0.2%), quantity not specified
Drug Purpose: Lubricant eye drops used to relieve dry eye symptoms
Recall Reason: Lack of assurance of sterility.
Recall Initiation Date: April 28, 2026
Link: FDA Enforcement Report
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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Albuterol, Buspirone, Cinacalcet, Claravis, Furosemide, Omega-3-Acid Ethyl Esters, and Pantoprazole. Also, these over-the-counter eye drops are under recall: GenTeal Tears Lubricant Eye Gel Drops, Systane Lubricant Eye Gel, iVIZIA Sterile Lubricant Eye Drops, and Optase Dry Eye Intense Drops.</p>
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<p>All of the recalls in this installment have been assigned a “Class II” level by the FDA, except for Buspirone, which was assigned “Class III.” The recall for Claravis has not yet been classified. All are nationwide supplier-level recalls and not directed at consumers. However, consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates.</p>
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<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified."</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
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<li>Class I recalls are the most serious. In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death."</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<div role="region" class="wp-block-accordion-panel"><!-- wp:paragraph -->
<p><br>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.</p>
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<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.<br></p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Albuterol Sulfate Inhalation Solution</h3>
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<p><strong>Company</strong>: Nephron SC, LLC<br><strong>Manufacturing Location</strong>: West Columbia, South Carolina by Nephron 503B Outsourcing <strong>Facility Scope</strong>: 146,280 vials of 0.5% strength<br><strong>Drug Purpose</strong>: Treats bronchospasm — a narrowing of the airways that makes breathing difficult — in asthma and other lung diseases. This formulation is administered using a nebulizer, which turns the medication into an inhalable mist.<br><strong>Recall Reason:</strong> Problem with labeling; the drug label was illegible.<br><strong>Recall Initiation Date</strong>: March 17, 2026<br><strong>Essential Extras</strong>: <a href="https://nephronpharm.com/outsourcing/">Nephron 503B Outsourcing Facility</a> is a division of Nephron Pharmaceuticals Corporation, primarily selling products to hospitals and medical facilities. It is <a href="https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities">registered </a>at the FDA as Nephron Sterile Compounding Center LLC.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98596">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">BusPIRone Hydrochloride Tablets (generic for Buspar)</h3>
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<p><strong>Company</strong>: Unichem Pharmaceuticals USA Inc.<br><strong>Manufacturing Location</strong>: Ghaziabad, India, by Unichem Laboratories LTD.<br><strong>Scope</strong>: 10,875 (500-count) bottles of 5 mg strength tablets<br><strong>Drug Purpose</strong>: Treats generalized anxiety disorder and/or provides short-term relief of anxiety symptoms<br><strong>Recall Reason</strong>: Subpotent drug; the amount of active ingredient was less than the allowable range.<br><strong>Recall Initiation Date</strong>: April 13, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98728">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Cinacalcet Hydrochloride Tablets (generic for Sensipar)</h3>
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<p><strong>Company</strong>: Cipla USA, Inc.<br><strong>Manufacturing Location</strong>: Cipla Ltd., MIDC, Patalganga, India<br><strong>Scope</strong>: 113,336 30-count bottles of 30 mg strength; 96,096 30-count bottles of 60 mg strength; 63,192 30-count bottles of 90 mg strength tablets<br><strong>Drug Purpose</strong>: Treats secondary <a href="https://medlineplus.gov/ency/article/001215.htm">hyperparathyroidism</a> (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: March 16, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98670">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Claravis Capsules</h3>
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<p><strong>Drug Name</strong>: Claravis (isotretinoin) capsules<br><strong>Company</strong>: Teva Pharmaceuticals USA, Inc.<br><strong>Manufacturing Location</strong>: North Wales, Pennsylvania by Teva<br><strong>Scope</strong>: 5,101 cartons of 10 mg capsules (includes 100-count cartons of 10X10 blister packs and 30-count cartons of 3X10 blister packs)<br><strong>Drug Purpose</strong>: Treats severe cystic acne that has not responded to other treatments<br><strong>Recall Reason</strong>: Impurity levels in tretinoin exceeded acceptable limits, which may affect stability and effectiveness.<br><strong>Recall Initiation Date</strong>: April 6, 2026; this recall is not yet classified; this is a nationwide and Virgin Islands recall.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98730">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Furosemide Tablets (generic for Lasix)</h3>
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<p><strong>Company</strong>: Leading Pharma, LLC<br><strong>Manufacturing Location</strong>: Fairfield, New Jersey<br><strong>Scope</strong>: 9,384 bottles (100-count) of 80 mg strength tablets<br><strong>Drug Purpose</strong>: Diuretic that treats high blood pressure, heart failure, and edema.<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications"> Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: March 20, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98628">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Omega-3-Acid Ethyl Esters Capsules (generic for Lovaza)</h3>
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<p><strong>Company</strong>: Harvard Drug Group / Major Pharmaceuticals<br><strong>Manufacturing Location</strong>: Packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana<br><strong>Scope</strong>: 2,238 cartons of 1 g strength, 10-unit dose blister packs of capsules<br><strong>Drug Purpose</strong>: A prescription fish oil–derived treatment used to lower very high triglyceride levels.<br><strong>Recall Reason</strong>: Failed stability testing.<br><strong>Recall Initiation Date</strong>: April 9, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98763">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Pantoprazole Tablets (generic for Protonix)</h3>
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<p><strong>Company</strong>: Hetero Labs Limited<br><strong>Manufacturing Location</strong>: Mahabubnagar, India; manufactured by Hetero Labs Ltd. for Camber Pharmaceuticals<br><strong>Scope</strong>: 4,740 bottles (1,000-count) of 40 mg strength tablets <br><strong>Drug Purpose</strong>: Proton pump inhibitor used to treat erosive esophagitis, often caused by acid reflux.<br><strong>Recall Reason</strong>: Complaints were received about tablet discoloration.<br><strong>Recall Initiation Date</strong>: March 26, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98671">FDA Enforcement Report</a></p>
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<h2 class="wp-block-heading">Eye Drop Recalls</h2>
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<h3 class="wp-block-heading">GenTeal Tears Lubricant Eye Gel Drops and Systane Lubricant Night Gel</h3>
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<p><strong>Company</strong>: Alcon Research LLC<br><strong>Manufacturing Location</strong>: GenTeal manufacturing location not specified, distributed by Alcon Laboratories; Systane product processed in France for Alcon Laboratories<br><strong>Scope</strong>: Unspecified number of bottles of GenTeal Tears 10 g (0.34 fl oz) and Systane Night Gel 10 g (0.35 oz)<br><strong>Drug Purpose</strong>: Lubricant eye gels that are used to relieve dry eye symptoms<br><strong>Recall Reason</strong>: Lack of assurance of sterility.<br><strong>Recall Initiation Date</strong>: April 21, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98815">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">iVIZIA Sterile Lubricant Eye Drops and Similasan iVIZIA Sterile Lubricant Eye Drops</h3>
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<p><strong>Company</strong>: Thea Pharma<br><strong>Manufacturing Location</strong>: France; distributed by Thea Pharma<br><strong>Scope</strong>: Five lots of 0.33 fl oz (10 mL) bottles (Povidone 0.5%)<br><strong>Drug Purpose</strong>: Lubricant eye drops used to relieve dry eye symptoms<br><strong>Recall Reason</strong>: Lack of assurance of sterility identified during an FDA facility inspection.<br><strong>Recall Initiation Date</strong>: April 23, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98792">FDA Enforcement Report<br></a><strong>Essential Extras</strong>: iVIZIA posted a detailed recall announcement on its website with lot numbers, product photo, expiration dates, and instructions to consumers: <a href="https://www.ivizia.com/recall/">Ivizia Recall Announcement</a></p>
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<h3 class="wp-block-heading">Optase Dry Eye Intense Drops</h3>
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<p><strong>Drug Name</strong>: Optase Dry Eye Intense Drops<br><strong>Company</strong>: Scope Health<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 0.33 fl oz bottles (Glycerin 0.2%), quantity not specified<br><strong>Drug Purpose</strong>: Lubricant eye drops used to relieve dry eye symptoms<br><strong>Recall Reason</strong>: Lack of assurance of sterility.<br><strong>Recall Initiation Date</strong>: April 28, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219851">FDA Enforcement Report</a></p>
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